
Radwa Moustafa El-Gammal
Regulatory Affairs manager
Sheikh Zayed, Giza, EgyptWork Experience
Regulatory Affairs managerFull Time
- Job Details:Manage The regulatory affairs (RA) department by obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. Place imported SKUs in market, by insuring completion of its logistics cycle. Develop and manage process for regulatory compliance of raw materials and finished products and provide oversight for registration/approvals of raw materials, processing aid, food additives,finished products and import/export activities. Compile application dossiers and interact with authorities for getting product approvals/Proprietary approvals. Provide strategic approach on regulatory aspects during new product development process. Coordinate the activities internally and collaborate with the team in the factories who is involved with government audits/inspection/sampling. Coordinate the preparation of action plans generated by audits or regulatory visits or sampling and communicate to government in collaboration with Corporate Affairs. Lead and train people in businesses involded in regulatory compliance activities. Assess on regular basis and advise regulatory needs of the country for businesses operations. Support trade associations activities or projects related to technical aspects of the legislation such as registration, labels, specifications. Provide regulatory input for any business new product/project when required.
Product registration and compliance senior specialistFull Time
AlShaya
Apr 2017 - Feb 2020 -2 yrs, 10 months
Egypt
- Job Details:Registration of cosmetics, skin and hair care range of products for Alshaya brands such as The Body Shop, Victoria's Secret, H&M, Mother Care, and Bath & Body Works
Regulatory Affairs SpecialistFull Time
Vamer Pharmaceutical
Jun 2015 - Mar 2017 -1 yr, 9 months
Egypt , Cairo
- Job Details:- Prepares, assembles & presents the documentation required for submission to regulatory authorities(CAPA, NODCAR) in order to register the company’s new products and maintain existing registrations.
Product specialistFull Time
Bayer healthcare
Jul 2013 - Jun 2015 -1 yr, 11 months
Egypt , Cairo
- Job Details:*Training Executive (Short term assignment) Managing the yearly Training Needs Analysis Prepare yearly Training Calendar Maintaining All training records and staff competencies Monthly Training Report Monitoring On Job Training Report *Product Specialist • Responsible for the promotion of Xarelto in Giza Key accounts
Education
Technical Diploma in executive management
American University in Cairo (AUC)Jan 2010 - Jan 2012 - 2 yr
Bachelor's Degree in pharmacy
Misr International University (MIU)Jan 2005 - Jan 2010 - 5 yr
High School - IGCSE
Orouba Language SchoolsJan 2005
Skills
- Microsoft Office
- Internet
- Regulatory Affairs
- Business Planning
- Presentation Skills
- Communication
- Sales
- medical detailing
- Training
- Business Planning
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Languages
Arabic
FluentEnglish
FluentFrench
Beginner
Training & Certifications
emotional intellegence
Eli Lilly·2012insights
insights company int·2012selling & communication skills
Eli Lilly·2011